ISO 22675-2006 修复术.足-踝器械和足部组件的试验.要求和试验方法
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【英文标准名称】:Prosthetics-Testingofankle-footdevicesandfootunits-Requirementsandtestmethods
【原文标准名称】:修复术.足-踝器械和足部组件的试验.要求和试验方法
【标准号】:ISO22675-2006
【标准状态】:现行
【国别】:国际
【发布日期】:2006-10
【实施或试行日期】:
【发布单位】:国际标准化组织(IX-ISO)
【起草单位】:ISO/TC168
【标准类型】:()
【标准水平】:()
【中文主题词】:残疾人辅助器具;踝;人造足;定义;设计;测定;耐久性;动态试验;人类工效学;足;设备;脚;寿命;肢;负荷;载荷试验;材料;医学科学;矫形外科学;器械矫形装置;精密度;修复装置;规范(验收);静荷载;材料强度;应力;专门装备;试验;试验条件
【英文主题词】:Aidsforthedisabled;Ankles;Artificialfeet;Classificationsystems;Conformity;Definitions;Design;Designations;Determination;Durability;Dynamictesting;Ergonomics;Feet(anatomy);Finemechanics;Fitments;Foot;Life(durability);Limbs;Loading;Loadingtests;Materials;Medicalsciences;Orthopedics;Orthoticdevices;Performancerequirements;Precision;Proofloading;Prostheticdevices;Specification(approval);Specimens;Staticloading;Strengthofmaterials;Stress;Symbols;Technicalaid;Testforces;Testing;Testingconditions
【摘要】:IMPORTANT—ThisInternationalStandardissuitablefortheassessmentoftheconformityofprostheticankle-footdevicesandfootunitswiththestrengthrequirementsspecifiedin4.4ofISO22523:2006(seeNOTE1).Prostheticankle-footdevicesandfootunitsonthemarket,whichhavedemonstratedtheircompliancewiththestrengthrequirementsspecifiedin4.4ofEN12523:1999throughsubmissiontotherelevanttestsofISO10328:1996,neednotberetestedtothisInternationalStandard.ThisInternationalStandardprimarilyspecifiesacyclictestprocedureforankle-footdevicesandfootunitsofexternallowerlimbprostheses,distinguishedbythepotentialtorealisticallysimulatethoseloadingconditionsofthecompletestancephaseofwalkingfromheelstriketotoe-offthatarerelevanttotheverificationofperformancerequirementssuchasstrength,durabilityandservicelife.Thispotentialisofparticularimportancefortheassessmentoftheperformanceofavarietyofrecentdesignsofankle-footdevicesandfootunitswithspecificcharacteristicsthatwillonlydevelopunderrealisticconditionsofloading.Inaddition,thisInternationalStandardspecifiesastatictestprocedureforprostheticankle-footdevicesandfootunits,consistingofastaticprooftestandastaticultimatestrengthtest,distinguished,besidesotherfeatures,(seeNOTE2)bythepotentialtogenerateheelandforefootforcesatlinesofactionconformingtothoseoccurringattheinstantsofmaximumheelandforefootloadingduringthecyclictest.Theloadingconditionsaddressedinthethirdparagrapharecharacterizedbyaloadingprofiledeterminedbytheresultantvectoroftheverticalandhorizontal(A-P)groundreactionforcesandbyalocomotionprofiledeterminedbythetibiaangle.ThetestloadingconditionsspecifiedinthisInternationalStandardarecharacterizedbystandardizedformatsoftheseloadingandlocomotionprofiles,tobeuniformlyappliedbythecyclicandstatictestprocedurestoeachsampleofankle-footdeviceorfootunitsubmittedfortest.AccordingtotheconceptofthetestsofthisInternationalStandard,eachsampleofankle-footdeviceorfootunitsubmittedfortestis,nevertheless,freetodevelopitsindividualperformanceunderload.NOTE1ISO22523(formerlyEN12523)addressesthoseoftheEssentialRequirementslistedinAnnexIoftheEuropeanMedicalDeviceDirective93/42/EECthatareapplicabletoexternallimbprosthesesandexternalorthoses.NOTE2ThelinesofactionoftheheelandforefootforcesgeneratedbythestatictestprocedurespecifiedinthisInternationalStandardapproachthosedeterminingthesagittalplaneloadingofthetestloadingconditionsIandIIfortheprincipalstructuraltestsspecifiedinISO10328,withoutchangingthevaluesoftheanglesoftheheelandforefootplatform(s)forthestructuraltestsonankle-footdevicesandfootunitsspecifiedinISO10328.
【中国标准分类号】:C45
【国际标准分类号】:11_180_10
【页数】:92P;A4
【正文语种】:英语
【原文标准名称】:修复术.足-踝器械和足部组件的试验.要求和试验方法
【标准号】:ISO22675-2006
【标准状态】:现行
【国别】:国际
【发布日期】:2006-10
【实施或试行日期】:
【发布单位】:国际标准化组织(IX-ISO)
【起草单位】:ISO/TC168
【标准类型】:()
【标准水平】:()
【中文主题词】:残疾人辅助器具;踝;人造足;定义;设计;测定;耐久性;动态试验;人类工效学;足;设备;脚;寿命;肢;负荷;载荷试验;材料;医学科学;矫形外科学;器械矫形装置;精密度;修复装置;规范(验收);静荷载;材料强度;应力;专门装备;试验;试验条件
【英文主题词】:Aidsforthedisabled;Ankles;Artificialfeet;Classificationsystems;Conformity;Definitions;Design;Designations;Determination;Durability;Dynamictesting;Ergonomics;Feet(anatomy);Finemechanics;Fitments;Foot;Life(durability);Limbs;Loading;Loadingtests;Materials;Medicalsciences;Orthopedics;Orthoticdevices;Performancerequirements;Precision;Proofloading;Prostheticdevices;Specification(approval);Specimens;Staticloading;Strengthofmaterials;Stress;Symbols;Technicalaid;Testforces;Testing;Testingconditions
【摘要】:IMPORTANT—ThisInternationalStandardissuitablefortheassessmentoftheconformityofprostheticankle-footdevicesandfootunitswiththestrengthrequirementsspecifiedin4.4ofISO22523:2006(seeNOTE1).Prostheticankle-footdevicesandfootunitsonthemarket,whichhavedemonstratedtheircompliancewiththestrengthrequirementsspecifiedin4.4ofEN12523:1999throughsubmissiontotherelevanttestsofISO10328:1996,neednotberetestedtothisInternationalStandard.ThisInternationalStandardprimarilyspecifiesacyclictestprocedureforankle-footdevicesandfootunitsofexternallowerlimbprostheses,distinguishedbythepotentialtorealisticallysimulatethoseloadingconditionsofthecompletestancephaseofwalkingfromheelstriketotoe-offthatarerelevanttotheverificationofperformancerequirementssuchasstrength,durabilityandservicelife.Thispotentialisofparticularimportancefortheassessmentoftheperformanceofavarietyofrecentdesignsofankle-footdevicesandfootunitswithspecificcharacteristicsthatwillonlydevelopunderrealisticconditionsofloading.Inaddition,thisInternationalStandardspecifiesastatictestprocedureforprostheticankle-footdevicesandfootunits,consistingofastaticprooftestandastaticultimatestrengthtest,distinguished,besidesotherfeatures,(seeNOTE2)bythepotentialtogenerateheelandforefootforcesatlinesofactionconformingtothoseoccurringattheinstantsofmaximumheelandforefootloadingduringthecyclictest.Theloadingconditionsaddressedinthethirdparagrapharecharacterizedbyaloadingprofiledeterminedbytheresultantvectoroftheverticalandhorizontal(A-P)groundreactionforcesandbyalocomotionprofiledeterminedbythetibiaangle.ThetestloadingconditionsspecifiedinthisInternationalStandardarecharacterizedbystandardizedformatsoftheseloadingandlocomotionprofiles,tobeuniformlyappliedbythecyclicandstatictestprocedurestoeachsampleofankle-footdeviceorfootunitsubmittedfortest.AccordingtotheconceptofthetestsofthisInternationalStandard,eachsampleofankle-footdeviceorfootunitsubmittedfortestis,nevertheless,freetodevelopitsindividualperformanceunderload.NOTE1ISO22523(formerlyEN12523)addressesthoseoftheEssentialRequirementslistedinAnnexIoftheEuropeanMedicalDeviceDirective93/42/EECthatareapplicabletoexternallimbprosthesesandexternalorthoses.NOTE2ThelinesofactionoftheheelandforefootforcesgeneratedbythestatictestprocedurespecifiedinthisInternationalStandardapproachthosedeterminingthesagittalplaneloadingofthetestloadingconditionsIandIIfortheprincipalstructuraltestsspecifiedinISO10328,withoutchangingthevaluesoftheanglesoftheheelandforefootplatform(s)forthestructuraltestsonankle-footdevicesandfootunitsspecifiedinISO10328.
【中国标准分类号】:C45
【国际标准分类号】:11_180_10
【页数】:92P;A4
【正文语种】:英语
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